Kinrix Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Kinrix in Detail - Patient Information: Side Effects
Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.
Keep track of any and all side effects your child has after receiving this vaccine. If the child ever needs to receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.
Becoming infected with diphtheria, pertussis, tetanus, or polio is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if the child has any of these serious side effects:
- extreme drowsiness, fainting;
- fussiness, irritability, crying for an hour or longer;
- seizure (black-out or convulsions); or
- high fever.
Less serious side effects may include:
- redness, pain, tenderness, or swelling where the shot was given;
- mild fussiness or crying;
- low fever; or
- loss of appetite.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Kinrix (Diptheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Kinrix Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if any of these rare but serious side effects occur: high fever (105 degrees F/40 degrees C or higher), numbness/tingling, muscle weakness, difficulty breathing, seizures.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact the doctor or pharmacist.
Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Kinrix (Diptheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Kinrix FDA Prescribing Information: Side Effects
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared with rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice.
A total of 3,537 children were vaccinated with a single dose of KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) in 3 clinical trials. Of these, 381 children received a non-US formulation of KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) (containing ≤ 2.5 mg 2-phenoxyethanol per dose as preservative). The primary study (Study 048), conducted in the United States, was a randomized, controlled clinical trial in which children 4 to 6 years of age were vaccinated with KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) (N = 3,156) or control vaccines (INFANRIX and IPOL® vaccine [IPV, Sanofi Pasteur SA]; N = 1,053) as a fifth DTaP vaccine dose following 4 doses of INFANRIX and as a fourth IPV dose following 3 doses of IPOL. Subjects also received the second dose of US-licensed measles, mumps, and rubella (MMR) vaccine (Merck & Co., Inc.) administered concomitantly, at separate sites.
Data on adverse events were collected by parents/guardians using standardized forms for 4 consecutive days following vaccination with KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) or control vaccines (i.e., day of vaccination and the next 3 days). The reported frequencies of solicited local reactions and general adverse events in Study 048 are presented in Table 1.
In 3 studies (Study 046, 047, and 048), children were monitored for unsolicited adverse events, including serious adverse events, that occurred in the 31-day period following vaccination and in 2 studies (Study 047 and 048), parents/guardians were actively queried about changes in the child's the occurrence of serious adverse events, throughhealth status, 6 months post vaccination.
Table 1. Percentage of Children 4 to 6 Years of Age Reporting
Solicited Local Reactions or General Adverse Events Within 4 Days of Vaccination*
With KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) or Separate Concomitant Administration of INFANRIX and IPV When
Coadministered With MMR Vaccine (Study 048) (Total Vaccinated Cohort)
|KINRIX||INFANRIX + IPV|
|Local†||N = 3,121-3,128||N = 1,039-1,043|
|Pain, grade 2 or 3§||13.7||12.0|
|Pain, grade 3§||1.6‡||0.6|
|Redness, ≥ 50 mm||17.6||20.0|
|Redness, ≥ 110 mm||2.9||4.1|
|Arm circumference increase, any||36.0||37.8|
|Arm circumference increase, >20 mm||6.9||7.4|
|Arm circumference increase, >30 mm||2.4||3.2|
|Swelling, ≥ 50 mm||10.2||11.5|
|Swelling, ≥ 110 mm||1.4||1.8|
|General||N = 3,037-3,120||N = 993-1,036|
|Drowsiness, grade 3||||0.8||0.8|
|Fever, ≥ 99.5° F||16.0||14.8|
|Fever, >102.2° F||1.1||1.1|
|Fever, >104° F||0.1||0.0|
|Loss of appetite, any||15.5||16.0|
|Loss of appetite, grade 3¶||0.8||0.6|
|IPV manufactured by Sanofi Pasteur SA. MMR vaccine manufactured
by Merck & Co., Inc.
Total Vaccinated Cohort = all vaccinated subjects for whom safety data were available.
N = number of children with evaluable data for the events listed.
*Within 4 days of vaccination defined as day of vaccination and the next 3 days.
†Local reactions at the injection site for KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) or INFANRIX.
‡Statistically higher than comparator group (p < 0.05).
§Grade 2 defined as painful when the limb was moved; Grade 3 defined as preventing normal daily activities.
|| Grade 3 defined as preventing normal daily activities.
¶ Grade 3 defined as not eating at all.
In Study 048, KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) was non-inferior to INFANRIX with regard to swelling that involved > 50% of the injected upper arm length and that was associated with a > 30 mm increase in mid-upper arm circumference within 4 days following vaccination (upper limit of two-sided 95% Confidence Interval for difference in percentage of KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) [0.6%, n = 20] minus INFANRIX [1.0%, n = 11] ≤ 2%).
Serious Adverse Events: Within the 31-day period following study vaccination in 3 studies (Study 046, 047, and 048), in which all subjects received concomitant MMR vaccine (US licensed MMR vaccine [Merck & Co., Inc.] in Study 047 and 048; non-US licensed MMR vaccine in Study 046), 3 subjects (0.1% [3/3,537]) who received KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) reported serious adverse events (dehydration and hypernatremia; cerebrovascular accident; dehydration and gastroenteritis) and 4 subjects (0.3% [4/1,434]) who received INFANRIX and IPV (Sanofi Pasteur SA) reported serious adverse events (cellulitis; constipation; foreign body trauma; fever without identified etiology).
In addition to reports in clinical trials, the following adverse events, for which a causal relationship to components of KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) is plausible, have been reported since market introduction of DTaP-IPV manufactured by GlaxoSmithKline outside the U.S. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccination.
General Disorders and Administration Site Conditions: Injection site vesicles.
Skin and Subcutaneous Tissue Disorders: Pruritus. Additional adverse events reported following postmarketing use of INFANRIX, for which a causal relationship to vaccination is plausible, are: Allergic reactions, including anaphylactoid reactions, anaphylaxis, angioedema, and urticaria, apnea, collapse or shock-like state (hypotonic-hyporesponsive episode), convulsions (with or without fever), lymphadenopathy, and thrombocytopenia.
Read the entire FDA prescribing information for Kinrix (Diptheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) »
Additional Kinrix Information
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